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Mesothelioma is a rare and serious cancer that affects the protective lining of organs in the body, particularly the lungs. While a number of clinical trials for mesothelioma are under way, most are in the early stages. Physicians say the relatively small number of patients with mesothelioma makes the disease difficult for researchers to study.

Mesothelioma Clinical Trials: What’s Out There?

“Clinical trials are tough to mount with this patient population,” says Neil Schachter, MD, medical director of respiratory care and a professor of pulmonary medicine at the Mount Sinai Medical Center in New York City. With only about 3,000 new cases diagnosed every year, it is hard to design meaningful clinical trials, Dr. Schachter explains.

Many of the current National Cancer Institute (NCI) clinical trials on mesothelioma involve combining various medications with other treatment approaches. The majority of these trials are early stage or Phase I trials. In a Phase I clinical trial, the goal is to evaluate the safety, rather than the effectiveness, of a particular method of treatment. Phase II clinical trials examine whether the treatment actually works.

Examples of current NCI-sponsored trials on mesothelioma include:

A Phase I study involving gene therapy and chemotherapy

A Phase I trial on chemotherapy and radiation

A Phase I study of immunotherapy, designed to encourage the body's natural defenses to combat cancer cells, plus chemotherapy

A Phase II trial evaluating the use of surgery, chemotherapy, and radiation in mesothelioma

Although mesothelioma is a relatively uncommon cancer, there are a number of cutting-edge clinical trials combining newer therapies with standard chemotherapy, notes Raffit Hassan, MD, senior investigator and chief of the solid tumor immunotherapy section in the Laboratory for Molecular Biology at the National Cancer Institute’s (NCI) Center for Cancer Research. “For example, at NCI, we have two ongoing clinical trials combining monoclonal antibodies [special proteins designed to attack cancer cells] with chemotherapy for treatment of newly diagnosed patients with mesothelioma,” he says.

Despite the innovative studies that are under way, however, Bartolome R. Celli, MD, chief of pulmonary care at St. Elizabeth’s Medical Center in Boston, points out that many of the medications being examined in other clinical trials haven't been designed specifically to treat mesothelioma. “Several drugs are being used, but mostly they are drugs used in other cancers,” he notes. Again, the fact that mesothelioma is such a rare cancer makes it tougher for researchers to develop and test more targeted therapies in clinical trials.

Mesothelioma Clinical Trials: The Risks of Participation

Like everything else, clinical trials have pros and cons.

You should expect to do some traveling for your treatment and testing, unless you happen to live in the same city where the trial is taking place. Also, you may end up being disappointed if you don't qualify for a clinical trial. Clinical trials usually have very specific criteria for participation including whether you've ever received certain medications or other mesothelioma treatments. Talk to your oncologist about whether you'd be a good candidate for a particular trial.

Since clinical trials involve therapies that have not been previously studied, you're at risk of unanticipated side effects. Depending on the type of clinical trial you participate in, there's also a risk of not actually receiving the new, experimental treatment. Some trials compare new therapies to existing treatments, so you may just end up with the standard treatment.

Mesothelioma Clinical Trials: The Pros of Participation

Clinical trials are typically carried out at leading cancer treatment facilities. Participating in a clinical trial allows you access to health care professionals who are often experts in dealing with mesothelioma. As a result, simply being involved in a trial can sometimes improve your overall medical care. Additionally, there is also the chance that your mesothelioma will respond better to a therapy being studied in a clinical trial than to standard therapy.

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